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False Results?

6/24/2002      

MONDAY, June 24 (HealthScoutNews) --If you think you might be pregnant, you probably want to know as soon as possible.

However, there's a good chance you'll need to wait until just after you've missed your period -- not three days before it's expected, as the promotional material can be interpreted on some pregnancy kits.

Doctors say so-called early-result pregnancy tests waste time and money.

Studies on the packaging of such kits as First Response say 48 percent of women get a "false negative" result when they test three days before their expected period. In other words, the test told nearly half of the women they weren't pregnant when, in fact, they were.

"It's a waste of money, and it's a waste of time," says Dr. Shari Brasner, an ob-gyn at Mt. Sinai Hospital in New York City. "I can't really think of a scenario in which it's so critical to know four days earlier."

To be fair, the makers of the early-pregnancy tests aren't trying to keep the "false negative" rate a secret. The front of the First Response box says "Now! Test 4 Days Earlier Than Any Other At-Home Test!," but the statistic on the false negative rate is on the back.

"Our instructions and claims are approved by the FDA," says David Fox, senior director of marketing for Church & Dwight Inc., the Princeton, N.J.-based manufacturer of First Response. "We strongly believe it's in the best interest of women's health to learn as early as possible if they are pregnant."

The company's tests also found 31 percent of women will get a false negative two days before their period and 14 percent one day before.

Not surprisingly, the press release that raised questions about early-result pregnancy tests came from a public relations firm that represents one of First Response's top competitors.

With 29 percent of the market, e.p.t is the best-selling brand, according to an independent market research firm. First Response, with 13 percent, is No. 2.

e.p.t's instructions tell women to test the first day after they miss their period. On that day, laboratory tests show, they can expect 99 percent accuracy.

That's the same accuracy rate women an expect with nearly all pregnancy tests on the market, including First Response and Clearblue Easy, Brasner notes.

Annette Young, product manager for e.p.t, says putting the false negative in the fine print is misleading because many women never bother to read it.

Ninety percent of those surveyed at the American College of Obstetricians and Gynecologists meeting in Los Angeles recently said the best time for a women to take a home pregnancy test is after she has missed her period.

"We know from our research that accuracy is the most important thing that people look for in these tests," Young says. "It's far more important than the speed of a pregnancy test."

In true corporate fashion, each company puts a different spin on the same statistics. The makers of e.p.t say the danger of "false negative" results is that women, mistakenly believing they are not pregnant, will go back to behavior that could put their health of their baby at risk, including smoking and drinking.

However, the makers of First Response say their product gives women the chance to know as early as possible if they are pregnant, so they can do things like stop drinking and smoking immediately.

"It's very important that women who, in fact, are pregnant learn as early as they possibly can because of the healthy living steps they would want to take," Fox says. "They just need to realize the earlier they test, the more likely they don't have the appropriate amount of hormone" for the test to be accurate.

Pregnancy tests measure the level of human chorionic gonadotropin (hCG), a hormone produced by the placenta during pregnancy, in the urine. The rate at which hCG is generated varies among women, Brasner says.

She does not recommend a particular brand of pregnancy test to her patients.

"All of the over-the-counter tests today are very sensitive," she says. "I do not routinely recommend that women come in for blood tests anymore to confirm pregnancy because the tests are such a fabulous tool. I rely on them."

She does, however, say women should save their money and wait until after their period to test. Pregnancy tests cost from $8 to $12 at most stores.

"They will know soon enough," she says. "You avoid this whole discussion of 'Maybe it's a false negative. Maybe I am really pregnant.' If it's done appropriately, there is an overwhelming good chance that a positive is a true positive and a negative is a true negative."

What To Do

To read more about pregnancy tests, check out FertilityPlus or Onna.

SOURCES: Shari Brasner, M.D., ob-gyn, Mt. Sinai Hospital, New York City; David Fox, senior director, marketing, Church & Dwight Inc., Princeton, N.J.; Annette Young, product manager, e.p.t, Morris Plains, N.J.

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